Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)

Airway Management Clinical Trial

— REDECAP  

Official title:

Reducing Decannulation Time in Critically-ill Tracheostomized Patients: Decannulation Capping Trial Protocol vs Frequency Aspiration Protocol (REDECAP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512744
• Other study ID #: 3/7/2015 n67
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2018
• Source: Hospital Virgen de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols:

1. based on capping trials to decide decannulation,

2. based on the aspiration frequency to decide decannulation time. High-flow conditioned oxygen therapy will be applied to all patients through the tracheal cannula. In patients included in the suctioning frequency based protocol along the study period and in patients included in the capping trial protocol along periods out of capping trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).

Exclusion Criteria:

• Patients consedered non-decannulable at time of randomization:

1. unconscious patient (motor component of GCS score <6 points).

2. Severe swallowing function (based on drink test).

3. Airway patency problem (based of intolerance of occlusion test).

4. Neuromuscular diseases.

5. Patients with a Sabadell score >2.

Related Conditions & MeSH terms

• Airway Management
• Respiratory Therapy
• Tracheostomy

Intervention

Procedure:
• Decannulation protocol.
Comparison of two different decannulation protocols: one protocol based on capping trial tolerance to decide when to decannulate vs. protocol based on suctioning frequency of respiratory secretions to decide when to decannulate (criteria: =2 aspirations every 8 h along 24 consecutive hours).

Device:
• High flow conditioned oxygen therapy
High flow conditioned oxygen therapy will be applied during all study period through tracheal cannula in the experimental arm (suctioning frequency based protocol) and during periods out of capping trials in the control arm (capping trials based protocol).

Locations

Country	Name	City	State
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitario Vall D´Ebron	Barcelona
Spain	Hospital Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Virgen de La Salud	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Virgen de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decannulation time	Time since weaning from mechanical ventilation (24 consecutive hours disconnected) to decannulation	Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary	Decannulation failure	Number of patients requiring recannulation during hospital stay / number of patients included in the group X 100	Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary	Intensive Care Unit Lenght of stay	Time since ICU admission to ICU discharge	Patients will be followed for the duration of ICU stay, an expected average of 2 months
Secondary	Hospital lenght of stay	Time since hospital admission to hospital discharge	Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary	ICU mortality	ICU mortality in every study group	Patients will be followed for the duration of ICU stay, an expected average of 2 months
Secondary	Hospital mortality	Hospital mortality in every study group	Patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary	Respiratory infection	Post-randomization pneumonia and tracheobronchitis rate in every study group	Patients will be followed for the duration of hospital stay, an expected average of 3 months